Arphion is a company established to develop noninvasive products that will be used to diagnose, prevent, and treat head and neck and other cancers. 41,000 people are diagnosed with head and neck cancer (HNC) every year in the United States, with 8,000 deaths. Tens of millions of people in the US are at increased risk for HNC due to exposure to the polycyclic aryl hydrocarbons (PAHs) found in tobacco and some foods. Other risk factors are involved, because although many millions of people in the US are exposed to high levels of tobacco PAHs and a second risk factor, ethanol, only a small minority will get the disease. Curiously, the changes in oral bacteria that occur with tobacco-induced periodontal disease somehow also increase the risk for HNC. Dr. Joel Schwartz's team has recent evidence that may explain the connection between oral bacteria and cancer. They showed that tobacco users have excess numbers of 8 different oral microbial species that can metabolize PAHs, and that the metabolism can increase reactivity of these molecules. We hypothesis that these microbes, which we refer to as 8BAC, play a major role in DNA adduct formation in the oral mucosa, a key early step in formation of most HNC. Arphion plans to show that 8BAC is linked to mucosal DNA adduct formation in humans and that rapid PCR/DNA sequencing based measurement of 8BAC microbes in a patient's mouth will correlate to DNA adduct levels. Arphion's product would detect elevated levels of 8BAC as a surrogate for DNA adducts in cellular DNA, which are difficult and expensive to measure. Patients at high risk for HNC with high levels of 8BAC would be advised to change their tobacco consumption, and to have semiannual head and neck cancer exams. A second goal of this Phase I research is to show a firm link between 8BAC microbes and HNC by showing 8BAC is elevated in patients with this disease versus matched subjects who are HNC- free. Arphion's product will identify among smokers, and others with high carcinogen exposure, those most likely to go on to HNC. This will provide true cancer prevention by facilitating behavior modification. Our plan, after a successful Phase II, where we verify the link between 8BAC levels and mucosal DNA adduct levels, is to partner with a large firm with experience with automated DNA isolation and analysis, and knowledge of FDA regulatory requirements so we can begin providing kits to dental practitioners who will then send preserved samples to Arphion for analysis on a fee-for-test basis.